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This randomized controlled study aims to evaluate the effects of skin closure using surgical staplers compared with conventional skin sutures on postoperative pain and wound healing in primiparous women undergoing episiotomy repair after vaginal delivery.
Primiparous women who require episiotomy during vaginal birth will be randomly assigned to one of two groups: skin closure with staples or skin closure with sutures. Postpartum pain levels and wound healing outcomes will be assessed and compared between the two groups.
The results of this study are expected to contribute to evidence-based decisions regarding optimal skin closure techniques in episiotomy repair.
Full description
Episiotomy is one of the most commonly performed obstetric interventions during childbirth (Sherif & El-Shourbagy, 2020; Shahrahmani et al., 2017; Woldegeorgis, 2022). Although it shares similar characteristics with spontaneous second-degree perineal tears, episiotomy was routinely performed for many years. However, routine episiotomy practices began to be questioned in the late 1970s and 1980s, and its use declined during the 1990s. Factors contributing to this change include increased health awareness among women, the natural childbirth movement, professional competition, and the widespread adoption of evidence-based practices (Chang et al., 2011).
Pain associated with episiotomy is a significant issue that negatively affects women's quality of life in the postpartum period. A woman's request for analgesia is considered a medical indication for pain management. Inadequate pain control reduces the effectiveness of therapeutic interventions (JahaniShoorab et al., 2015). Episiotomy-related pain decreases maternal comfort, negatively affects mother-infant bonding, reduces breastfeeding success, and may even influence women's childbirth preferences due to fear of labor and episiotomy pain (Beşen & Rathfisch, 2019; Shahrahmani et al., 2017; Temizkan, 2018).
The ideal method for episiotomy repair should be fast, easy to perform, cause minimal tissue trauma, and result in minimal postpartum pain and dyspareunia. Closure techniques that minimize skin trauma reduce inflammation and scarring by limiting the introduction of foreign materials. Various techniques have been proposed for postpartum episiotomy repair, including non-suturing of the incision, continuous locking sutures, and interrupted non-locking sutures (Deyaso, 2022; Feigenberg et al., 2014; Sherif & El-Shourbagy, 2020; Swenson et al., 2019). Regardless of the technique used, successful tissue approximation is associated with less pain and wound infection, better cosmetic outcomes, and shorter hospital stays.
In recent years, traditional repair methods have increasingly been replaced by modern techniques such as skin staples, tissue adhesives, and adhesive strips (Figueroa et al., 2013; Sherif & El-Shourbagy, 2020; Teixeira et al., 2020). Skin staples, one of these modern methods, are described as a faster and more reliable repair technique (Akopov, Artioukh & Molnar, 2021). Due to their fixed depth and uniform structure, staples provide equal wound tension, which is thought to reduce pain and promote wound healing in episiotomy skin repair.
The aim of this study is to determine the effects of using staples versus surgical sutures in episiotomy skin repair on postpartum localized pain and wound healing.
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Inclusion and exclusion criteria
Inclusion Criteria: Participants will include primiparous women over 18 years of age with term pregnancies who have no obstetric risk, who do not receive oxytocin induction during the latent or active phases of labor, who are carrying a live fetus, who have no psychiatric disorders or substance dependence, and who have first- or second-degree perineal tears. Participants who read, understand, and voluntarily accept the informed consent form both verbally and in written form will be included in the study.
Exclusion Criteria: Participants with an Apgar score <7 at the 1st and 5th minutes, neonatal anomalies, use of more than 10 mL of analgesic during episiotomy repair (beyond routine practice), obesity, vaginal infection or lesions, maternal diseases that impair wound healing (e.g., diabetes mellitus, immunosuppression, and coagulation disorders), third- or fourth-degree perineal tears, or labor dystocia will be excluded from the study.
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24 participants in 2 patient groups
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Central trial contact
Aysegul Kanik, MSc
Data sourced from clinicaltrials.gov
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